GPED for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of GPED (gemcitabine, pegaspargase, etoposide, and dexamethasone) regimen in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: treatment arm Treated with gemcitabine, pegaspargase, etoposide and dexamethasone |
Drug: Gemcitabine
1000mg/㎡,d1,4 ivdrip
Drug: Pegaspargase
2500IU/㎡, maximum dose less than 3750IU
Drug: Etoposide
100mg/㎡,d1-3 ivdrip
Drug: Dexamethasone
20mg/d d1-4 ivdrip
|
Outcome Measures
Primary Outcome Measures
- overall response rate [24 weeks ±7 days]
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Secondary Outcome Measures
- complete response rate [24 weeks ±7 days]
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
- 1-year progression free survival rate [up to 1year after enrollment]
time from date of enrollment to date of disease progression, death of any reason, whichever comes first
- 1-year overall survival rate [up to 1year after enrollment]
time from date of enrollment to date death of any reason
Eligibility Criteria
Criteria
Inclusion Criteria:
Histopathology and immunohistochemistry confirmed diagnosis of NK/Tcell lymphoma according to WHO 2016 criteria.
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refractory or relapsed after initial remission, or stage III-IV de novo patients
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PET/CT or CT/MRI with at least one objectively evaluable lesion.
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General status ECOG score 0-3 points.
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The laboratory test within 1 week before enrollment meets the following conditions: Blood routine: Hb>80g/L, PLT>50×10e9/L. Liver function: ALT, AST, TBIL ≤2 times the upper limit of normal. Renal function: Cr is normal. Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking.
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Sign the informed consent form
Exclusion Criteria:
Active infection requires ICU treatment. Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are notexcluded.
Significant organ dysfunction Pregnant and lactating women. Had a history of autoimmune diseases, and disease was active in the last 6 months.
Those who were known to be allergic to drugs in the study regimen. Patients with other tumors who require surgery or chemotherapy within 6 months.
• Other experimental drugs are being used.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Beijing Tongren Hospital | Beijing | China | 100730 |
Sponsors and Collaborators
- Beijing Tongren Hospital
Investigators
- Principal Investigator: Liang Wang, M.D., Beijing Tongren Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TRhos-ENKTCL-7